GlucoTrack, Inc. (Nasdaq: GCTK) (“GlucoTrack” or the “Company”), a non-invasive device and digital health platform for measuring glucose levels in people with Type 2 diabetes and prediabetes announced today that it has provided an update on the development of GlucoTrack 2.0 (or “Gen 2”).
In early Q2 the Company completed lab testing of its Gen 2 clinical prototype system. This process included testing of multiple iterations of electronics, ear clip, and mobile app with cloud-based software. In addition, human factors testing of the mobile app has been completed through simulated use in focus groups and by conducting a rigorous external design review for system architecture, stability, and cybersecurity.
The completion of bench testing and analyses of the Gen 2 clinical prototype system was followed by simulated use testing. During this in-house testing, the Company achieved better than expected accuracy and performance.
Initial data collected indicates that the Gen 2 system may achieve an accuracy comparable to invasive Continuous Glucose Monitors (CGM’s) currently available in the market when conducting the upcoming first-in-human clinical study.
The Company has recently received Ethics Committee and clinical center approvals to conduct this study at the Rabin Medical Center in Israel. The initial results from this study will drive a follow-up multi-center study in the United States, led by Dr. Klonoff, Chair of the Company’s Scientific Advisory Board and Medical Director of the Diabetes Research Institute of Mills-Peninsula Medical Center. The U.S. study is intended to be a precursor to the eventual pivotal trial for FDA clearance. The Company aims to begin its first-in-human study in Israel in Q3 and in U.S. centers in Q4. In addition, these positive results are driving a design re-assessment that the Company believes will lead to a more user-friendly system with a lower cost and faster measurement time than initially targeted.
“I am greatly encouraged by the promising early results of the testing of the Gen 2 clinical prototype system and by the opportunity that lays ahead of us” said Paul Goode, CEO and President. “We thank our shareholders for their encouragement and patience and look forward to providing further updates on our progress.”
GlucoTrack, Inc. (NASDAQ: GCTK), (formerly known as Integrity Applications, Inc.) is focused on the design, development, and commercialization of non-invasive glucose monitoring technologies for people with type 2 diabetes and prediabetes. The Company has developed GlucoTrack®, a proprietary non-invasive glucose monitoring device designed to obtain glucose level measurements without the pain, incremental cost, difficulty, or discomfort of conventional invasive finger stick devices. GlucoTrack, Inc. is a Delaware corporation, with headquarters in the United States and an R&D site in Or Yehuda, Israel. For more information, please visit http://www.integrity-app.com/ and http://www.glucotrack.com. Investor Contact: firstname.lastname@example.org